oxymetazoline hcl

Product NDC: 45802-410
11-digit product format: 458020410
Labeler code: 45802
Product ID: 45802-410_999f909c-4119-4f4e-9093-6438801b878d
Type: HUMAN OTC DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-12-05
Marketing end: 2027-02-28
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: oxymetazoline hcl

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K89MJ0S5VY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a1103cd8-344b-4a65-8a60-3c7be86d01a6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-410-59	oxymetazoline hcl	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		7
45802-410-59	oxymetazoline hcl	1 in 1 CARTON	SPRAY	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-410-59	ML - Milliliter	45802-410	54e747ad-1a30-4db2-8182-ca670b35ec25	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-410	OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]	7	Current NDC, Legacy NDC, 2 package rows	20240912_a1103cd8-344b-4a65-8a60-3c7be86d01a6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b	2026-02-17	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	e8a48a00-3533-4c4d-94e1-8a6c6b35a792	2026-02-17	Warnings	Exact identifier application number: M012
cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	HyVee Inc	1f3efcdd-4976-4aef-a7c6-a5f88d13cb78	2026-02-17	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	HyVee Inc	d5bbb5e1-ff09-4563-b2c6-149ab30e06ad	2026-02-17	Warnings	Exact identifier application number: M012
Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Chain Drug Marketing Association, Inc.	3c8f34ad-589a-4872-939c-44ad5e0e47fe	2026-02-17	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Valu Merchandisers Company	b6144732-99da-4be2-88e0-75f31b323d38	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M012
topcare day time cold and flu relief multi symptom relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Topco Associates LLC	6d08ca2d-6ae4-443f-9920-34b7fb46f2b4	2026-02-16	Warnings	Exact identifier application number: M012
Revasol Acetaminophen Suspension	ACETAMINOPHEN	Rnv LLC	4ab6bb54-7c28-0c6b-e063-6394a90ac4a6	2026-02-13	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Topco Associates LLC	62eed0e8-ba5f-45c2-a543-68b50bcf4b0c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M012
Revasol Acetaminophen Suspension Dye Free	ACETAMINOPHEN	Rnv LLC	4abc07b3-6a27-260f-e063-6394a90a28d6	2026-02-13	Warnings	Exact identifier application number: M012
robafen dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Major Pharmaceuticals	5e19220d-9cf3-4732-b9aa-c09db5d69ce6	2026-02-13	Warnings	Exact identifier application number: M012
Gencare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	686b9456-f16d-4b99-ae58-f607448bed8b	2026-02-13	Warnings	Exact identifier application number: M012
nasal	PHENYLEPHRINE HYDROCHLORIDE	Kroger Company	1c3dc4e6-452b-4c84-b53c-426cf9ae8f03	2026-02-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	af42d3f7-661e-4322-aefe-2b7f9f1010d6	2026-02-12	Warnings	Exact identifier application number: M012
Childrens Giltuss D	CHILDRENS GILTUSS D	Gil Pharmaceutical Corp	cfc2493b-e99e-4b55-98a9-053f95d49844	2026-02-12	Warnings	Exact identifier application number: M012
Giltuss D	GILTUSS D	Gil Pharmaceutical Corp	298f5457-a7df-474d-9854-68918ee3d330	2026-02-12	Warnings	Exact identifier application number: M012
Vaporizing	CAMPHOR	Walgreen Co.	ef4f95c8-7650-4096-9369-ea8393781bee	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M012
Oxymetazoline hydrochloride	OXYMETAZOLINE HYDROCHLORIDE	Prodose, Inc.	3dce34f0-9f6d-8151-e063-6394a90a1d38	2026-02-11	Warnings	Exact identifier application number: M012
SIGNATURE CARE Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	SAFEWAY	831da7b6-25c7-4601-b7f1-1800a238b016	2026-02-11	Warnings	Exact identifier application number: M012
Allergy Plus Congestion Relief	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0d2cf481-622f-4262-b0bd-c38fe5de6721	2026-02-11	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	e51dfb62-40d0-4bec-9574-90057cb35bcc	8
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	e51dfb62-40d0-4bec-9574-90057cb35bcc	8
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	e51dfb62-40d0-4bec-9574-90057cb35bcc	8
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	a1103cd8-344b-4a65-8a60-3c7be86d01a6	7
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	a1103cd8-344b-4a65-8a60-3c7be86d01a6	7
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	a1103cd8-344b-4a65-8a60-3c7be86d01a6	7
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	fd058e2b-5445-e416-e053-6394a90a611b	3
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	fd058e2b-5445-e416-e053-6394a90a611b	3
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	fd058e2b-5445-e416-e053-6394a90a611b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-410-59	45802041059	1 BOTTLE, SPRAY in 1 CARTON (45802-410-59) / 30 mL in 1 BOTTLE, SPRAY	2005-12-05	2027-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Oxymetazoline HCl 0.05% Drug Facts	NuCare Pharmaceuticals,Inc.	2025-06-03	HUMAN OTC DRUG LABEL	3
Oxymetazoline HCl 0.05% Drug Facts	A-S Medication Solutions	2024-11-06	HUMAN OTC DRUG LABEL	8
Oxymetazoline HCl 0.05% Drug Facts	Padagis Israel Pharmaceuticals Ltd	2024-09-11	HUMAN OTC DRUG LABEL	7